Lancet Infect Dis: BBIBP-CorV New Coronary Pneumonia Inactivated Vaccine Phase 1/2 study was successful.

In order to contain the Covid-19 pandemic, it is necessary to speed up the development of vaccines.
recently assessed the safety and immunogenicity of the inactivated Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-cov-2) candidate vaccine BBIBP-CorV in humans.
study was conducted in a randomized, double-blind, placebo-controlled phase 1/2 trial conducted at the Liang Park Center for Disease Control and Prevention in Shangqiu City, Henan Province, China.
healthy volunteers aged 18-80 were negative for serum-specific ICM/IgG SARS-Cov-2 antibodies at baseline screening, divided into 2 age groups (18-59 years and older) and given 2 doses of vaccine or placebo on the 0th and 28th days in dose sizes of 2 sg, 4 sg and 8 sg.
In the Phase 2 study, participants aged 18-89 were randomly vaccinated or placebody, where the vaccine group was divided into: 0 days 8 sg single vaccination, 0th and 14th days, 0th and 21st days and 0 and 28 days 2 vaccinations at a dose of 4 sg.
end point of the study was safety and tolerance, and the secondary endpoint was immunogenicity.
Phase 1 study, 192 volunteers, with an average age of 53.7 years, were 24 volunteers in each dosage group and placebo group.
42 (29 per cent) of the 144 vaccinators reported at least one adverse reaction in the first seven days of vaccination.
the most common adverse events were fever (4%, 4 and 8 μg fever rates were 4%, 4% and 8% in the 18-59-year-old dose group, and 4% in the 60 and above groups).
, adverse events were mild, and no serious adverse events occurred 28 days after vaccination.
participants aged 18-59, the average geometric titration of meso-antibodies for 42 days after vaccination was: 87.7 in the 2-g group, 211.2 in the 4-g group, 228.7 in the 80-year-old and above groups, and 2.07 in the placebo group.
phase 2 study, 448 volunteers, with an average age of 41.7 years, had 84 participants in each group.
23 percent of volunteers reported at least one adverse event in seven days.
1 patient who received a placebo of 4 μg developed stage 3 fever, which is self-limiting.
were mild, and the most common systemic adverse events were fever (1-2%).
the 28th day after vaccination, the antibody titration of 0,14 days was 169.5, 0, 21 days in 4 sg group was 282.7, 0, 28 days 4 sg group was 218.0, and on the 0th day 8 sg group was 14.7.
study concluded that the BBIBP-CorV new coronary pneumonia inactivated vaccine was safe and well-resistant.
the SARS-Cov-2 body fluid response was produced in all vaccine subjects on the 42nd day after vaccination.
response effect of 1 intensive vaccination combined with basic vaccination was better than that of single double dose.
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